GlaxoSmithKline Hiring for ViiV Healthcare (GSK) Head, Clinical Operations and Medical Writing at Durham, NC  Full Time

ViiV Healthcare is a global specialty HIV (Human Immunodeficiency Virus) company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV.

Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, in prevention, treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care.

We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic.

As an experienced Clinical Operations and Medical Writing expert, the ViiV Head of Clinical Operations and Medical Writing will work in close collaboration with ViiV R&D project teams to provide operational and strategic leadership to the HIV matrix teams by working with functional area partners to deliver robust, fit for purpose clinical development plans and ensure regulatory/clinical documents are delivered efficiently and to high quality standards. The role will have strategic oversight for operational delivery of clinical development plans and for medical writing needs across ViiV R&D, including line management of the ViiV clinical operations and medical writing staff and contract medical writers. You will also be responsible for managing the strategic relationship with GSK Global Clinical Operations and external clinical service providers, such as clinical research organizations and central lab providers.

The Head of Clinical Operations and Medical Writing will be based out of Branford, CT or Durham, NC or GSK House & is eligible for relocation assistance.

This role will provide/gives YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Develops strategy for and oversees operational aspects of all ViiV clinical trials in conjunction with ViiV project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations

• Develops strategy with and oversees the medical writing team providing support for the writing of selected clinical and regulatory documents from scientific and clinical project data to meet the needs of licensing authorities. Provides expert advice to clinical project teams on all matters relating to the production and publication of regulatory documents

• Creates strong strategic partnerships with colleagues in ViiV Clinical Development, Regulatory, Clinical Pharmacology, Statistics and Data Management, Medical Affairs, and GSK Global Clinical Operations to ensure consistent approaches to study delivery, data collection and reporting across a program and delivery of key clinical and regulatory documents

• Line management of clinical operations staff (including clinical operations directors and medical writing) to include mentoring, coaching and development of people both in the direct team and the wider team

• Identify and deliver clinical operations resource strategy for clinical studies and medical writing support

• Develop strategy and provide oversight for the operational aspects of clinical studies, including CRO and service provider management, site and country selection, site monitoring, clinical study budget estimates

• Represents Clinical Operations and proposed operational strategy during program governance/review meeting interactions including (but not limited to) EDC, PRF/PRC, RDGM LT and PIC.

• Represents ViiV at book of work meetings with clinical vendors, such as CROs providing full service outsourcing, clinical lab support, and other clinical facing work

• Develops clinical trial diversity strategy with EDTs/MDTs/CMTs and ViiV Clinical Trial Diversity Task Force and oversees delivery for clinical trial diversity via interaction and oversight of GSK Clinical Trial Diversity team and CROs

• Develops strategy and delivery model with the Medical Writing team for delivery of clinical and regulatory documents to support early development and medicine development teams

• Provides ViiV representation on procurement discussions for clinical and medical writing vendors

• Manages the relationship with GSK Global Clinical Operations for effective delivery of ViiV Clinical studies and associated clinical and regulatory documentation

• Provides Enterprise leadership to improve standards, establish and disseminate best practice, streamline processes, increase efficiency, and reduce costs for clinical trial and medical writing delivery

• Ensures ViiV HC clinical teams embed best practices from service provider clinical development acceleration workstreams (e.g., GSK Upper Quartile)

• Ensures ViiV HC clinical teams embed study delivery model (e.g., STOM) from GSK, leads ViiV input to and execution of these new clinical team models.

• Collaborates with ViiV Head of GCP Quality to ensure study delivery is conducted in compliance with GCP and creates strategies to ensure GCP compliant delivery for clinical studies

• Manages clinical operations aspects of partnerships with external clinical trial networks such as DAIDS networks (e.g., HPTN, IMPAACT, ACTG) and PENTA when associated studies are utilized for product registration or label extension

• Provides oversight to and manages best practices, including change management, for ViiV HC clinical trial country selection

Why you?Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s of Science degree & 7 plus years of pharmaceutical experience

• Experience in clinical operations in the pharmaceutical industry or CRO environment

• Experience working with investigators, external experts, Contract Research Organizations and vendors

• Experience leading in a matrix environment to develop clinical plans and deliver projects

• Knowledge of program management (including resource and financial management), global regulatory guidelines and ICH/GCP

• Leadership experience with senior stakeholder management

• Experience with marketing application submissions (e.g, MAA, NDA, BLA, JNDA) and/or regulatory document creation (e.g. IND, Protocol, CSR, Investigator Brochure)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• MS, PhD, or PharmD

• Demonstrated ability to establish and build highly functional internal and external relationships at all levels in a highly dynamic and matrixed environment

• Demonstrated ability to use robust analytical rigor to identity the critical issue in complex situations and to frame issues and opportunities in such a way that new perspectives can be found

• Highly developed communication skills appropriate to the target audience which promote effective decision-making

• Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks and build internal capability

• Actively promotes a culture of empowerment and identifies opportunities to delegate responsibility

• Enterprise thinker with an ability to understand and balance the broader business needs with the needs of their specific projects

Why ViiV Healthcare (GSK)?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
• Managing individual performance.
• Creating a performance culture and driving results, prioritisation, execution, delivering performance.
• Setting strategic direction and leading on-going organisational transformation.
• Building a resilient organisation.
• Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
• Managing P&L and capital allocation.

#LI-ViiV

#LI-GSK

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 38 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.

We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between and in 2009, with joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.

Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do – from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we’re all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.

If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV’s compliance to all federal and state US Transparency requirements. For more information, please visit ViiV’s Transparency Reporting site.

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.